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Pelvic Floor Exercises for Suboptimal Anorectal Manometry

Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07062731
Enrollment
50
Registered
2025-07-14
Start date
2025-06-15
Completion date
2027-09-15
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Anal Sphincter Injury

Keywords

pelvic floor muscle exercises

Brief summary

Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg. This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)

Interventions

BEHAVIORALSupervised pelvic floor muscle exercises

4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)

Sponsors

King's College Hospital NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and: 1. Are at least 6 weeks postpartum 2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum 2. Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment. 3. Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits. 4. Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.

Exclusion criteria

* Inclusion Criteria 1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and: 1. Are at least 6 weeks postpartum 2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum 2. Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment. 3. Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits. 4. Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.

Design outcomes

Primary

MeasureTime frameDescription
Success4 months1. Change of incremental squeeze pressure from abnormal (\<20mmHg) or suboptimal (20-40mmHg) to normal (\>40mmHg) 2. Change of incremental squeeze pressure from abnormal (\<20mmHg) to suboptimal (20-40mmHg)

Secondary

MeasureTime frameDescription
Change or recommended mode of delivery4 monthsChange of recommended mode of delivery from elective Caesarean section only to spontaneous vaginal delivery or elective Caesarean section
Change in St Mark's Score4 monthsChange in St Mark's score before and after intervention
Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)4 monthsChange in ICIQ-UI SF before and after intervention
Change in Faecal Incontinence Quality of life Scale4 monthsChange in Faecal Incontinence Quality of life Scale before and after intervention

Countries

United Kingdom

Contacts

Primary ContactKar Yee Lor, MBChB
kch-tr.anopress-research@nhs.net+442032993568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026